This invention relates to compositions and methods for inactivating viruses and retroviruses present in blood, other body fluids and, more generally, biological fluids, and to articles used in the practice of such methods.
Human Immunodeficiency Virus (HIV), the causative agent of AIDS, is currently being spread in epidemic proportions in susceptible populations around the world. Two different serotypes of the virus, designated HIV-1 and HIV-2, have been identified. In patients infected with HIV, contaminating virus can frequently be cultivated from body fluids including blood, urine, cerebrospinal fluid, tears, semen and salivary secretions. The presence of virus in these fluids constitutes a health risk not only for uninfected individuals who are exposed to them, but especially for health care workers who must treat infected patients.
Transmission of HIV infection to transfusion recipients by virally contaminated blood and/or blood products has been well-documented. Over one thousand cases of HIV infection acquired via blood transfusion have been reported in the United States. In addition, it is estimated that an additional 12,000 individuals may have acquired the virus by this route between 1978 and 1984 before routine screening for HIV was instituted in blood banks. It is estimated that 90-100% of recipients of such HIV-contaminated transfusions become infected. Although routine serological testing of donated blood began in 1985, a significant risk of HIV infection for blood transfusion recipients still exists because of limitations in the HIV-screening procedures. Current testing procedures (which involve screening for antibodies to HIV) may fail to identify HIV-infected blood donors for at least six months post infection and chronic carriers of HIV sometimes test negative even in the presence of progressive HIV infection.
Moreover, health care workers who become infected by blood-borne virus by accidental needle sticks and blood spills constitute another risk group that is independent of the screening procedures and their limitations.
Another risk group includes sex partners of HIV-infected individuals. Transmission of HIV infection by virally contaminated semen apparently accounts for the spread of HIV by sexual contact. Although transmission of infection by virally contaminated urine, cerebrospinal fluid, tears or saliva has not been reported, risk of such transmission is present nonetheless.
Numerous chemical and physical methods have been used in an effort to inactivate HIV present in biological fluids or in the laboratory equipment used to analyze such fluids. Exposure to alcohols such as ethanol or isopropanol, paraformaldehyde, buffered formalin, hydrogen peroxide, hypochlorite, detergents such as NP-40, heat, high and low pH, as well as commercial disinfectants (such as LYSOL.RTM.) are the most widely employed techniques for inactivating HIV. These agents show varying degrees of effectiveness in inhibiting the viral reverse transcriptase activity of HIV or otherwise reducing the number of infectious HIV particles. However, virtually all of these techniques would interfere with the known clinical tests for detection of HIV, particularly those tests that are dependent on maintaining the viability of cells or infectious agents (other than HIV) that are present in the sample to be tested. A further drawback is that these agents are not appropriate for use in blood or blood products intended for transfusion. Also, use of the known agents by health care workers involved in handling blood or other body fluids, or in transfusing potentially infected blood or blood products, is often impractical.
The use of Nonoxynol-9 (nonylphenoxypolyethoxyethanol, a spermicidal polyethoxylated phenol) and other spermicidally active compounds as a lubricant or coating in condoms and other contraceptive articles and preparations has been reported to inactivate HIV. Nonoxynol-9 has been reported to be effective against free virus at concentrations in excess of 0.05% (vol/vol). However, Nonoxynol-9 may not inactivate the virus when it is present within HIV-infected cells, a source of infectious HIV.
Accordingly, what is needed in the art is a method for treating biological fluids in order to inactivate viral particles and in particular retroviruses such as HIV which may be present in these fluids, before the contaminated fluid causes an individual to become infected.
Therefore, it is the object of the present invention to provide a method, articles and compositions for inactivating viruses and especially retroviruses that may be present in body fluids.
Another object of the present invention is to provide a method, articles and compositions for inactivating HIV and other viruses and retroviruses present in whole blood and in other body fluids.
These and other objects of the present invention will be apparent to those of ordinary skill in the art in view of the present description, appended claims and accompanying drawings.